Entarik Feeding Tube System Placement in Adult ICU

Description

The purpose of this study is to evaluate the safety and effectiveness of the Entarik Feeding Tube System in an adult ICU patient population for the administration of nutrition, fluids and medications.

Conditions

Nasogastric Tube

Study Overview

Study Details

Study overview

The purpose of this study is to evaluate the safety and effectiveness of the Entarik Feeding Tube System in an adult ICU patient population for the administration of nutrition, fluids and medications.

Entarik Feeding Tube System Placement in Adult ICU

Entarik Feeding Tube System Placement in Adult ICU

Condition
Nasogastric Tube
Intervention / Treatment

-

Contacts and Locations

Bradenton

Nova Clinical Research at HCA Florida Blake Hospital, Bradenton, Florida, United States, 34209

Richmond

HCA Chippenham and Johnston-Willis Medical Center, Richmond, Virginia, United States, 23225

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Must be able to swallow tabletsAt least 18 years old
  • * Able to provide informed consent or ability to have a legally authorized representative provide informed consent
  • * Adults in the ICU requiring an 8Fr, 10Fr, or 12Fr NG tube. The size of the feeding tube should be determined clinically, and the Entarik Feeding Tube should only be placed if that size is appropriate.
  • * Suitable to start enteral (gastric but no post-pyloric) feeding
  • * Anticipated to receive enteral feeding (either bolus or continuous feeds) for more than 6 hours and conclude the enteral nutrition while in the care of the ICU. If enteral nutrition has already been initiated, indicated for replacement of an NG feeding tube Note: Both subjects on a ventilator (non-invasive or invasive ventilation) or not requiring a ventilator are eligible for this study.
  • * inability to receive a feeding tube including subjects with known history of issues such as esophagitis or strictures, frequent nose bleeds, basilar skull fracture or GI bleeding disorders
  • * Known major upper airway malformation
  • * Known major GI abnormality, upper GI malignancy, or partial gastric resection
  • * History of gastroparesis
  • * Currently pregnant
  • * NPO status - expected to remain NPO for the following 72 hours.
  • * Patient needs an MRI in the immediate future (e.g., 6-12h) where placement of the feeding tube (non-MRI compatible) is going to mandate replacement with standard feeding tube
  • * Critically ill, facing imminent death
  • * Deemed unsuitable for enrollment in study by the investigator based on subject's history (e.g., active anticoagulation therapy) or physical examination

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Gravitas Medical, Inc.,

Study Record Dates

2024-12